Senior Statistical Programmer - II

Senior Statistical Programmer II is responsible for producing the SAS programs, output, study reports for clinical trial programs, independently performing quality control on the statistical outputs, and achieving First Time Right outputs. This position may function as study lead programmer on assigned projects and/or and act as Subject matter expert (SME).

Key Responsibilities:

Maintain the highest level of professionalism, productivity, and quality of assigned projects

Manage or lead project assignments and programming team for multiple and complex studies

Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, Company Standard procedures and policies

Actively participate in Project, kick off meeting, to understand the project scope, plan and timelines, and detailed project specific requirements

Develop and/or validate specification for SDTM, ADaM, and Derived datasets

Develop and/or validate programming for CDISC SDTM, ADaM, and derived datasets (Moderate-Complex)

Develop and/or validate programming for integration of databases from multiple studies and sources.

Develop and/or validate programming, and documentation of statistical programs for use in creating statistical tables, figures, and listings.

Develop and/or validate the programming for utility and project specific macros.

Create and/or review define packages [Define.xml], and Reviewers guide [RGs] for CDISC Data standards

Maintain, verify and ensure the quality and accuracy of all assigned tasks to achieve First Time Right outputs

Timely completion of client specific and organization specific training documentation

Assist QA review

Learn in progress and develop skill sets and competencies to perform the job role

Provide mentorship to associates within statistical programming group Communicate to management on project status and resource issues

Perform other duties as assigned by Department Head or Immediate Supervisor

Education, Skill Experience:

Any bachelor or master s degree, preferably in Computer Science, Engineering, Mathematics, Statistics or Life Sciences

Minimum 6-8 years of relevant SAS programming experience for any clinical trial phases and demonstrate the ability to independently perform SAS programming

Good working knowledge in all phases of clinical trials

Exposure in working in various therapeutic areas

Proficient in clinical industry standards, CDISC Data standards, ICH-GCP Regulatory guidelines, medical terminology and clinical trial methodologies

Excellent verbal and written communication skills